HCC Translational Research Laboratory, Barcelona-Clínic Liver Cancer Group, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Liver Unit, Hospital Clínic, Barcelona, Catalonia, Spain.
J Hepatol. 2013 Aug;59(2):392-5. doi: 10.1016/j.jhep.2013.03.025. Epub 2013 Mar 30.
The high failure rate of phase 3 trials in oncology is forcing the scientific community to rethink drug development strategies and optimize trial design. The current paradigm of systemic therapies is progressively favoring molecular-based patient selection. In hepatocellular carcinoma, four out of the five phase 3 trials that tested molecular therapies in the last 5 years have been negative. None of them included enriched populations using predicted biomarkers of response. Hence, there is an increasing need to provide new targets and refine selection criteria in HCC clinical trials using molecular readouts of tumor biology.
肿瘤学 3 期临床试验的高失败率迫使科学界重新思考药物开发策略并优化试验设计。目前，系统治疗的范例正逐渐偏向基于分子的患者选择。在肝细胞癌中，过去 5 年中测试分子疗法的 5 项 3 期临床试验中有 4 项为阴性。其中没有一项试验使用预测反应生物标志物来富集人群。因此，越来越需要使用肿瘤生物学的分子读出物在 HCC 临床试验中提供新的靶点并完善选择标准。
